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Procedure

Therapeutic Hypothermia for Hearing Preservation During Cochlear Implants

N/A

Recruiting

Research Sponsored by Restorear Devices LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Equal number of men and women

Must not have

Subjects under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the use of mild therapeutic hypothermia during cochlear implant surgery to see if it can help preserve any remaining hearing. They want to find out if it is safe and effective

Who is the study for?

This trial is for individuals undergoing cochlear implant surgery who are interested in trying a new method to preserve their remaining hearing. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

What is being tested?

The study is testing the safety and effectiveness of using mild therapeutic hypothermia during cochlear implant surgery. It involves comparing outcomes between patients receiving this cooling therapy and those who do not (control group).

What are the potential side effects?

While specific side effects are not listed, mild therapeutic hypothermia may include risks such as local discomfort or changes in ear sensation due to the cooling process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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The study aims for an equal male and female participant ratio.

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I have severe hearing loss that is not due to ear conditions.

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I have been diagnosed with severe to profound hearing loss.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and at initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pure Tone Audiometry

Secondary study objectives

Electrically Evoked Compound Action Potential (ECAP)

Electrophysiological Impedance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Safety StudyExperimental Treatment1 Intervention

Aim 1: Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal.

Group II: Efficacy Study CoolingExperimental Treatment1 Intervention

Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal during cochlear implant surgery.

Group III: Efficacy Study ControlActive Control1 Intervention

Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive standard of care (no cooling) during cochlear implant surgery.

0 / 5Eligibility criteria met